Secure Dispensing System

ABSTRACT

A secure dispensing system comprising a container ( 10 ) arranged to dispense a quantity of a material through a delivery port ( 40 ). The system has a locking mechanism to prevent the dispensing of the material and a control device ( 70 ) to enable release of the locking mechanism. A key ( 110 ) is also provided to allow access to restricted functions of the system. The system will only enable release of the locking mechanism once a user has been authenticated by one or more biometric means of identification. The key ( 110 ) may also comprises a biometric means of authentication which must be provided in order to functionalize the key ( 110 ).

The present invention relates to a secure dispensing system, comprisinga container with a locking mechanism, which prevents the dispensing ofmaterial from the container until the locking mechanism is released. Thesecure dispensing system also comprises a control device, which isarranged to enable the release of the locking mechanism thereby allowingmaterial to be dispensed from the container. Preferably a key is alsoprovided to enable access to restricted functions of the system. Thesystem will only enable release of the locking mechanism when a user hasbeen authenticated by one or more biometric means of identification.More preferably, but not exclusively, the secure dispensing systemcomprises RFID tags as a means to communicate with various parts of thesystem. More preferably, but not exclusively, the secure dispensingsystem is used to dispense a pharmaceutical product. Preferably thesecure dispensing system is able to trace the movement of material alongdifferent parts of a supply chain.

BACKGROUND TO THE INVENTION

The movement of goods from one destination to another or even simply thedispensing of these goods from a container may require more securitythan can be achieved by a simple lock and key assembly alone.

For example, pharmaceutical products are often valuable assets and assuch it is important to ensure that once these goods leave their pointof manufacture they are not diverted or lost in the supply chain.

It is extremely difficult to keep track of pharmaceutical goods due tothe fact that they are often manufactured at a site and then transportedvia several warehouses before finally arriving at their destinationpharmacy. This transit period may take several days or weeks and theincreased transit time and the number of different shipment holds thatthe goods arrive at and are transported out of, can proliferate thechances of the goods being diverted or lost.

In the case of pharmaceutical products which are controlled drugs ordrugs of abuse the requirement for the goods to be secure at all timesduring their shipment and dispensing is of utmost importance.

Once a pharmacist has dispensed a pharmaceutical product for example, aprescribed drug, to a patient all control over the drugs use and how itis taken is removed. This can cause many problems. In particular lack ofcontrol over pharmaceutical products, which are drugs of abuse can leadto serious problems if not dealt with.

Drugs of abuse are often opioid drugs (a term which includes not onlydrugs related chemically to morphine but also non-related structureswhich act at the same receptors in the brain). These include many of thecontrolled drugs listed in the 1971 Misuse of Drugs Act and other drugs,including fentanyl. Opioids are used primarily to alleviate pain,although some of the CNS mechanisms that reduce the perception of painalso produce euphoria, and as such opioid drugs may be taken fornon-medicinal purposes in order to obtain the euphoric effect on mood.This gives the potential for abuse.

Dependence on opioid drugs arises from repeated administration ofopioids and is characterised by an overwhelming need to continue takingthe drug or one with similar properties. Users develop a tendency toincrease the dose owing to development of tolerance, and may develop apsychological and physical dependence on the drug. Cross-tolerance andcross-dependence exists between opioids acting at the same receptors.Opioid analgesics, particularly diamorphine, are abused for theireuphoric effects and dependence develops rapidly with regular use.

Methadone is a synthetic opioid, which is used as an analgesic and coughsuppressant and as an alternative to diamorphine for treating opioidaddicts. It is well absorbed orally, and when given to patients who areaddicted to other opioids produces less acute oscillations between thehigh and early withdrawal symptoms. Withdrawal may develop more slowlywith methadone than diamorphine.

Opioids themselves, such as methadone, are often used in the managementof other opioid, particularly heroin, dependency. The usual method inthe UK is to replace the diamorphine with methadone, which is given as aliquid oral preparation; this is then gradually withdrawn over a periodof time. In other countries, other opioids such as buprenorphine may beused in for example, sublingual tablets or nasal spray form. Methadoneis useful for withdrawal therapy because it can be given orally and itslong half-life allows once-daily administration. Liquid oralpreparations are usually preferred, and in withdrawal programmes it isusual for patients to attend pharmacies, or other treatment centreswhere the prescribed dose is given under supervision.

The average dose of methadone is between 60 and 120 mg per day.Methadone is available to pharmacies and clinics in a variety of formssuch as; 1 mg/ml solution (500 ml bottle), 10 mg/ml solution in a 150 mlor a 500 ml bottle, 325 g bulk powder for preparation or ampoules atvarious concentrations.

The Drug Tariff Formula (DTF) of methadone is a solution of methadonehydrochloride in an aqueous solution of hydrogenated glucose syrup(Maltitol). It has a bitter taste, and this determines the volume andconcentration that can be given at one time.

A patients access to managed doses of controlled drugs or drugs of abusesuch as, for example, diamorphine and methadone, often must be underclose professional supervision.

Although supervised administration of defined doses of an opioid is arecognised strategy for the treatment of diamorphine addicts, itrequires the input of healthcare professionals, time and counseling tobe effective.

Ideally, formulations in treatment regimens need to be presented inconvenient formats, preferably with facilities available for recordingdates and/or times of usage so as to control dosages administeredremotely, i.e. without requiring the supervision of healthcareprofessionals at the time of administration.

At the present time there is no safe and secure means for administrationof controlled drugs without close supervision of a healthcareprofessional. The high cost of supervision means that resources to treatpatients may be limited. In the absence of close professionalsupervision the controlled drug or drug of abuse could be diverted tothe black market or an overdose of the drug could be taken by thepatient.

The present invention addresses the scenario where it is desirable todispense pharmaceutical goods to a user via a secure dispensing system.The present invention describes a secure dispensing system and itscomponent parts where a user is authenticated by a biometric means ofidentification.

A preferred embodiment of the various aspects of the invention comprisesthe incorporation of a control device, which is able to provide controlover dispensing of the material within the container. Suitabletechnology for this level of control includes those described inGB2368061 and GB2368098, further improvements of which are described inGB2384707. Such systems generally comprise a dispenser, a lockingmechanism on the dispenser to prevent dispensing of the material, a userinterface allowing the user to input data, and a control device beingarranged to receive the input data and to enable release of the lockingmechanism to allow dispensing of the material.

The present invention obtains a further level of security over thedispensing systems described in the above applications as it requires auser to authenticate themselves to the system by a biometric means ofidentification. The use of a biometric means of identification overcomesthe problems associated with simpler identification means such asPersonal Identification Numbers (PIN) where a number can be easilydiverted to an unauthorised user.

Another advantage that the present invention demonstrates is that oncethe pharmaceutical product is secured within the container it cannot bediverted for illicit sale or use. Another advantage is that a patientcould not take more than their recommended daily dose.

When a drug of abuse such as methadone is supplied to a patient to takehome there is a danger of a patient overdosing from their medication ora child could mistakenly take the medication and suffer from an overdoseas a consequence to this.

Another clear advantage of the use of a secure dispensing system forsupplying a drug such as methadone is the reduction in costs that wouldoccur as a result. After the small initial outlay for the securecontainer and the control device, (both of which are reprogrammable andreusable), the costs of supplying methadone to treat an opiate addictare negligible. At present the cost of supervised consumption amounts tomore than £20 per week per patient and with an estimated 10,000 to15,000 patients currently undergoing supervised consumption of methadonein the UK, this amounts to a considerable cost.

In recent times there has been an increased need to supervise not onlythe patient but also the prescribing doctor and supplying pharmacist.

The use of this safer method of prescribing and supplying pharmaceuticalproducts means that there is a secure audit trail, which can be checkedat each level. This would mean that there was far less chance thatdoctors or pharmacists could misuse their position of authority toprescribe pharmaceutical goods.

SUMMARY OF INVENTION

According to a first aspect of the present invention, there is provideda secure dispensing system comprising the following:

-   -   a container arranged to securely contain a quantity of a        material within it comprising:        -   an internal locking mechanism to prevent unauthorised            dispensing of the material from the container; and        -   a delivery port to enable dispensing of a quantity of the            material from the container,    -   a control device arranged to enable release of the internal        locking mechanism to allow dispensing of the material once        authorization of a user has taken place; and    -   a key to enable a user to access restricted functions of the        system,    -   whereby the operation of the system is controlled by:    -   authentication of a first user to the key to enable the user to        access restricted functions of the system; and    -   authentication of a second user to the control device to enable        dispensing of the material from the container;        whereby the authentication means of the user is by measurement        of one or more biometric characteristics of the user.

The biometric means of identification of a user can be selected from anyknown biometric identification means. These include but are not limitedto hand geometry, retina scan, iris scan, fingerprint, facialcharacteristics, DNA sequence characteristics or voiceprints.

Preferably the biometric means of authentication is one or more of theusers fingerprints. The secure dispensing system may comprise means toscan and record one or more of a users fingerprints. In order toauthenticate a user to the system, the system requests that the userswipes one or more of his fingerprints. If the fingerprint that has beenswiped by the user matches the fingerprint that is stored by the systemthen the user is authenticated and can go on to access particularfunctions defined by the system. If the fingerprint does not match thefingerprint that is stored by the system then the user is notauthenticated and is asked to retry. If the user fails to provide anauthenticated fingerprint scan within a predetermined time period ornumber of attempts, the system may block the user until such a time thatan authorised person unblocks the system.

Once a user is authenticated to the system he is able to accessparticular functions defined by the system. These functions may include,but are not limited to, the user being given access to dispense a doseof medicament. Once the authentication process is complete a timerstarts whereby, for example, a dose can only be dispensed during a giventime span. This can be as short as several seconds or longer dependingon the requirements of the system and the user.

In order to ensure that the dispensing system is as secure as possiblethe container that contains the material that is to be dispensed ispreferably manufactured from a material that is resistant to tamper.This means that the container is constructed from a material that canresist attack from tools that are typically available from hardwarestores. The tools which are of particular interest, but are not limitedto, are electric power drills with hammer action, circular saws, JigSaws, Grinders with stone or metal discs, vice with 1 ton compressionpressure and a 21b club hammer dropped repeatedly on to the container.By resistant to attack it is meant that the container is able towithstand interference from a tool or device for a period of time thatis relevant to the type of tool. For example the use of a Jig Saw forover 30 minutes would render the Jig Saw blade blunt and useless andwould also probably overheat the device. The container is preferablyable to withstand tamper in this way.

In addition to the container being able to withstand attack from a toolthe container is also preferably bullet-proof.

Preferably to ensure that the container is tamper and bullet-proof thematerial that the container is manufactured from is a compositematerial.

The composite material may comprise, but is not limited to, thefollowing materials; aluminium, epoxy resin and silicon carbide. Othertypes of fibres or materials can be used to produce a composite materialfor use in the manufacture of the container. These include but are notlimited to glass, wood, metals, concrete, silicon carbide, ceramic andtitanium. The material can be woven or layered to produce a matrix.

The secure dispensing system further comprises a valve and pumpassembly, which is preferably inaccessible to the system user. Byinaccessible to the user it is meant that the valve and pump assembly isconcealed within the locked container or other inaccessible area of thesystem.

In addition the valve and pump assembly is preferably disposable. Bymaking the valve and pump assembly disposable it ensures that if thematerial that is to be dispensed is a poison or toxin or if the materialthat is to be replaced in the container is different from the materialthat is already in the container the valve and pump assembly will notcontaminate the new material.

Preferably the valve and pump assembly is also arranged in the containerto produce an indirect pathway to the delivery port. In this way thebest possible security is maintained as a user is unable to remove thecontents of the container by siphoning, suction or any other direct orindirect means.

The container has a delivery port from which the material held withinthe container is delivered through. Preferably the delivery port has avalve to prevent material from being extracted from the system'sdelivery port.

Preferably the container is a sealed unit with an internal lockingmechanism that can be opened by an authorised person to allow thecontents of the container to be replaced. In this way the container canbe cost-effective, because the container is durable a user may only everneed to be allocated with one container. An authorised person can carryout the replacement of the material inside the container.

The container may also be equipped with a biometric authenticationdevice. This is preferably a fingerprint scanner. The container can alsobe equipped with a tamper indicator, which would alert the user oranother person if the device had been opened or accessed in anunauthorised manner.

Another part of the secure dispensing system is the control device.Preferably, but not essentially, the control device is detachable fromthe container. This enables the control device to be used on more thanone container if necessary.

The control device may comprise a means for storing and transmittingdata. This enables the control device to collect information such as ausers biometric identification, information regarding the material thatis to be dispensed, a dispensing regime or information about how thesystem is being used. This information can either be stored andsubsequently downloaded when required or it can be transmitted to anauthorised location or person. More preferably the means for storing andtransmitting data is by one or more radio frequency identification(RFID) tags.

The control device preferably further comprises some or all of followingfeatures. A display screen, which can be used to facilitatecommunication with a user or other means of communication. A means forallowing data input, these could be simple buttons or more sophisticatedmeans of communication such as a voice or sound recognition. The controldevice can also be equipped with a tamper indicator, which would alertthe user or another person if the device had been opened or accessed inan unauthorised manner.

The control device can preferably communicate information to the user,this can be achieved by one of the means discussed above, although notlimited to these means.

The control device may also be equipped with a biometric authenticationdevice. This is preferably a fingerprint scanner.

According to a second aspect of the present invention, there is provideda key. The user of the key must firstly be authenticated in order tofunctionalize the key. Once authenticated to the key the user ispermitted to access restricted functions relating to the system.

Preferably the means of authentication of a user is a biometric means.More preferably the biometric means of authentication is one or more ofthe users fingerprints. The key may comprise means to scan and recordone or more of a users fingerprint. In order to authenticate a user, thekey requests that the user swipes one or more of their fingerprints. Ifthe fingerprint that has been swiped by the user matches the fingerprintthat is stored by the key the user is then authenticated, this enablesthe user to access specific functions of the secure dispensing system.If the fingerprint does not match the fingerprint that is stored by thekey then the user is not authenticated and is asked to retry. If a usermakes more unsuccessful attempts to authenticate themselves they may beblocked from using the key.

Preferably the key has means for storing and transmitting data. Morepreferably this means for storing and transmitting data is one or moreradio frequency identification (RFID) tags.

According to a third aspect of the present invention, there is provideda secure dispensing system whereby the different parts of the system areable to communicate with each other. Preferably this means ofcommunication is achieved by one or more radio frequency identification(RFID) tags or other similar means of storing, transmitting and/orretrieving data.

Preferably there is provided a plurality of RFID tags, which are able tocommunicate with one another in order to authenticate the variouscomponents of the system.

Preferably an RFID tag associated with the material contained within thecontainer communicates with an RFID tag reader associated with thecontainer, which in turn communicates with an RFID tag reader associatedwith the control device, and wherein the dispensing of the material willonly occur if the data that is communicated between the parts of thesystem is authorized by the system.

For example an RFID tag, which is associated with the contents of thecontainer communicates with an RFID tag reader associated with thecontainer this means that only material that is authorised to bedispensed from the container can be used. This method is of an advantageto ensure overall security of the system. For example if a bottle ofmedicament was placed inside the container and the type of medicamentwas not of the type required to be dispensed to a patient, an RFID tagassociated with the label on the medicament bottle would be read by anRFID tag reader associated with the container and this RFID tag would inturn communicate this information to an RFID tag associated with thecontrol device, thereby only allowing dispensing of the material ifauthenticated.

According to a fourth aspect of the present invention, the material thatis dispensed from the secure dispensing system is a pharmaceuticalproduct. Preferably but not essentially the material to be dispensed isa controlled drug or a drug of abuse.

Preferably the controlled drug or drug of abuse is a Class A drug asdefined by The Misuse of Drugs Act 1971. More preferably the controlleddrug or drug of abuse is an opioid. More preferably still the opioid ismethadone or a pharmaceutically acceptable salt or derivative thereof.Even more preferably the opioid is methadone hydrochloride.

Preferably the secure dispensing system is able to dispense a measureddose of material contained within it according to a pre-programmedregime. More preferably the measured dose of material can be deliveredin increments.

-   1. According to a fifth aspect of the present invention there is    provided a method of securely dispensing a material from a    container, said method comprising the steps of;    -   Authentication of a first user to a key by one or more biometric        means of identification;    -   Communication of the data produced by authentication to a means        for analysing the data;    -   Analysis of the communicated data to determine whether the first        user is permitted to access restricted functions of the system;    -   Access to restricted functions of the system if the first user        is authorised;    -   Authentication of a second user to a control device by one or        more biometric means of identification;    -   Communication of the data produced by authentication to a means        for analysing the data;    -   Analysis of the communicated data to determine whether        dispensing of the material from the container is permitted; and

Secure dispensing of material from the container if the second user isauthorised.

Preferably the biometric means of authentication is a scan of one ormore of the users fingerprints.

Preferably once the key is authenticated it allows the first user toopen the container to enable the contents of container to be replaced orfilled.

In addition, once authenticated to the key the user preferably hasaccess to programme the control device to enable dispensing of materialaccording to a regime.

Preferably, the communication of data between the control device and thecontainer is achieved by RFID tags.

Preferably the material to be dispensed is a pharmaceutical product.

Certain aspects of this invention may be understood by way of examplewith reference to the accompanying drawings in which:

FIG. 1 details the management of material along parts of a supply chain;and

FIG. 2 details the secure dispensing system of the invention.

SPECIFIC DESCRIPTION

One particularly preferred such device for dispensing a pharmaceuticalproduct will now be described, although it will of course be apparentthat the invention may be effected with alternative materials fordispensation.

Referring to the drawings, by way of example FIG. 1 details themanagement of material along parts of a supply chain. The flow chartdemonstrates the current way in which products such as pharmaceuticalsare moved along a supply chain and the amount of control that is heldover the pharmaceutical product at each point. At the first stage wherethe pharmaceutical product is manufactured complete control over theproduct is retained. But as the pharmaceutical product is moved fromthis site to wholesale distributors, then to the pharmacies, hospitalsand clinics and finally on to the patient, control over the product islost completely.

The callouts on the flow diagram detail the way in which the presentinvention aims to retain control over each step of the distributionchain. The use of a means for storing, receiving and/or transmittingdata such as, for example, a Radio Frequency Identification (RFID) tagin this way ensures that the whereabouts of the material is known at alltimes.

For example an RFID tag can be programmed at the point of a productsmanufacture to contain information such as the name of the product, typeor class of product, manufacturing date, expiry date, batch number etc.and this RFID tag can be applied to the product itself or to a labelassociated with the product. The product is then packaged for shippingwhere another RFID tag which has been programmed to contain informationsuch as the number of batches in the carton, supplier's details,shipment details etc. may be applied. Upon exiting the warehouse an RFIDtag reader may be used to record and log the details of the shipment.When the goods arrive at their destination and are logged in by an RFIDtag reader a communication can be sent to acknowledge that the goodshave arrived in a timely fashion at their destination. If they do notarrive an alert can be sent by the RFID tags associated with the goodsto warn that the goods are not at their destination.

When the point of destination is a pharmacy the goods can beautomatically logged into an electronic register, which can thenautomatically update if necessary once the pharmacy dispenses the goods.

By retaining control over all of these steps in the supply chain in thismanner it is clear that there is virtually no means of unauthoriseddiversion of the goods. When the goods are of such a nature that theyare valuable or addictive substances this is of clear importance.

FIG. 2 details the container from the secure dispensing system in bothfront and side elevation views. The container (10) is made from acomposite material and a dose delivery port (20). A dose may bedelivered directly to a drinking vessel for ease of dispensation to auser.

The container is produced in two parts, which are locked together by aninternal locking mechanism, which is inaccessible to the user. Thisenables the contents of the container to be refilled or replaced by anauthorised person when necessary.

The control device (30) of the secure dispensing system, is shaped insuch a manner that it is able to fit into the top of the container (10).Embedded contacts between the control device and the container allowdirect communication of data between the two parts of the system. Thecontrol device is equipped with a communication screen (40), which isable to communicate user specific information to the user. Function keys(50) allow the user to input data or information into the device. Afingerprint scanner (60) is included as part of the control device as ameans to measure a users identification. An indication button (70)enables the system to indicate to the user whether specific functionssuch as delivery of a dose of material from within the container isauthorised. For example, the indication button can be programmed to turngreen once the user has been authenticated to the control device and thecontrol device has authorised that a dose of the patients medicament maybe taken. The indication button can also be programmed to turn red if,for example, the user fails to be authenticated.

The key (80) is shown in situ attached to the control device. The keyonce inserted into the control device allows a user to be authenticatedto the control device. Once authenticated the user is allowed access tocertain restricted functions of the system. The key is removable fromthe control device.

The secure dispensing system described in the present invention could beused to contain a controlled drug such as methadone.

A patient that has been prescribed methadone by their doctor orhealthcare provider would take the prescription to their pharmacy.Alternatively the patient's doctor or healthcare provider directly tothe pharmacy could send an electronic prescription. Transfer of theprescription in this manner would ensure a secure transfer of theprescription ensuring that the prescription was not diverted in transitto the pharmacy.

The pharmacist would then fill the prescription and supply the drug tothe patient.

In order to do this the pharmacist would firstly authenticate himself orherself to a key. This would involve the pharmacist swiping one or moreof their fingerprints onto a fingerprint scanner and waiting for the keyto confirm that their fingerprints are accepted and they areauthenticated to access the restricted functions of the system.

Once this had been achieved the pharmacist would be able to instruct thecontrol device to unlock and open the container. He would then be ableto insert the prescribed medicament.

The pharmacist may also need to programme the control device to dispensethe drug to the patient in a regime. For example the patient may beprescribed with a dose of 60 ml per day. The pharmacist can programmethe control device to dispense the 60 ml dose in increments three timesa day between certain hours. In this way the patient would be able totake a 20 ml dose between 7:00 and 8:00. The patient could then accesstheir second dose between 15:00 and 16:00 and their third dose between23:00 and midnight.

This method of dosing is advantageous as it means that the patient doesnot have long periods of time between doses.

Once the filling and programming of the system is complete, thepharmacist would authenticate the patient to the device. This wouldinvolve swiping the patient's fingerprints across a fingerprint scanneron the container. An RFID tag in the control device would then recordthe information for use when authenticating a patient before taking adose is dispensed.

The patient is then able to take the secure dispensing system home andis in consequence able to dispense a dose of medicament according totheir pre-programmed schedule.

Changes to the programme may be made if and when necessary by thepatients doctor, pharmacist or healthcare provider. The changes can bemade either remotely by sending information directly to the patientscontrol device or manually by an authorised and authenticated person.

1. A secure dispensing system comprising the following: a containerarranged to securely contain a quantity of a material comprising: aninternal locking mechanism to prevent unauthorised dispensing of thematerial from the container; and a delivery port to enable dispensing ofa quantity of the material from the container, a control device arrangedto enable release of the internal locking mechanism to allow dispensingof the material once authorization of a user has taken place; and a keyto enable a user to access restricted functions of the system, wherebythe operation of the system is controlled by: authentication of a firstuser to the key to enable the user to access restricted functions of thesystem; and authentication of a second user to the control device toenable dispensing of the material from the container; whereby theauthentication means of the user is by measurement of one or morebiometric characteristics of the user.
 2. A secure dispensing system asclaimed in claim 1, wherein the biometric means of authentication isselected from; hand geometry, retina scan, iris scan, fingerprint,facial characteristics, DNA sequence characteristics or voiceprints. 3.A secure dispensing system as claimed in claim 2, wherein the biometricmeans of authentication is one or more of the users fingerprints.
 4. Asecure dispensing system as claimed in claim 1, wherein the container ismanufactured from a material that is resistant to tamper.
 5. A securedispensing system as claimed in claim 1, wherein the container ismanufactured from a material that is bullet-proof.
 6. A securedispensing system as claimed in claim 4, wherein the container ismanufactured from a composite material.
 7. A secure dispensing system asclaimed in claim 6, wherein the composite material comprises aluminium,epoxy resin and silicon carbide.
 8. A secure dispensing system asclaimed in claim 1, further comprising a valve and pump assembly, whichis inaccessible to the system user.
 9. A secure dispensing system asclaimed in claim 8, wherein the valve and pump assembly is disposable.10. A secure dispensing system as claimed in claim 8, wherein the valveand pump assembly is arranged in the container to produce an indirectpathway to the delivery port.
 11. A secure dispensing system as claimedin claim 1, wherein the delivery port has a valve to prevent materialbeing extracted from the system's delivery port.
 12. A secure dispensingsystem as claimed in claim 1, wherein the container can be opened toallow the contents of the container to be replaced.
 13. A securedispensing system as claimed in claim 1, wherein the control device hasmeans for storing and transmitting data.
 14. A secure dispensing systemas claimed in claim 1, wherein the control device comprises a displayscreen.
 15. A secure dispensing system as claimed in claim 1, whichfurther comprises means for allowing data input.
 16. A secure dispensingsystem as claimed in claim 1, wherein the control device is equippedwith a tamper indicator.
 17. A secure dispensing system as claimed inclaim 1, wherein the control device can communicate information to theuser.
 18. A secure dispensing system as claimed in claim 1, wherein thecontrol device is equipped with a biometric authentication device.
 19. Asecure dispensing system as claimed in claim 18, wherein the biometricauthentication device is a fingerprint scanner.
 20. A secure dispensingsystem as claimed in claim 1, wherein the control device is detachablefrom the container.
 21. A secure dispensing system as claimed in claim1, wherein the key comprises a biometric means of authentication, whichmust be provided in order to authenticate the user to the key.
 22. Asecure dispensing system as claimed in claim 1, wherein the key hasmeans for storing and transmitting data.
 23. A secure dispensing systemas claimed in claim 1, wherein the biometric means of authentication isby identification of one or more of a users fingerprint.
 24. A securedispensing system as claimed in claim 1, wherein authentication of auser to the key enables the user to access specific functions of thesystem.
 25. A secure dispensing system as claimed in claim 1, whereinthe different parts of the system are able to communicate with eachother.
 26. A secure dispensing system as claimed in claim 25, whereinthe communication between different parts of the system is achieved byone or more radio frequency identification (RFID) tags.
 27. A securedispensing system as claimed in claim 26, wherein a plurality of RFIDtags are able to communicate with one another to authenticate thecomponents of the system.
 28. A secure dispensing system as claimed inclaim 26, wherein an RFID tag associated with the material containedwithin the container communicates with an RFID tag reader associatedwith the container, which in turn communicates with an RFID tag readerassociated with the control device, and wherein the dispensing of thematerial will only occur if the data that is communicated between theparts of the system is authorized by the system.
 29. A secure dispensingsystem as claimed in claim 1, wherein the material to be dispensed is apharmaceutical product.
 30. A secure dispensing system as claimed inclaim 29, wherein the material to be dispensed is a controlled drug or adrug of abuse.
 31. A secure dispensing system as claimed in claim 30,wherein the controlled drug or drug of abuse is a Class A drug asdefined by The Misuse of Drugs Act
 1971. 32. A secure dispensing systemas claimed in claim 30, wherein the controlled drug or drug of abuse isan opioid.
 33. A secure dispensing system as claimed in claim 32,wherein the opioid is methadone or a pharmaceutically acceptable salt orderivative thereof.
 34. A secure dispensing system as claimed in claim34, wherein the opioid is methadone hydrochloride.
 35. A securedispensing system as claimed in claim 1, wherein the system is used todispense a measured dose of material according to a pre-programmedregime.
 36. A secure dispensing system as claimed in claim 35, whereinthe measured dose of material can be delivered in increments.
 37. Amethod of securely dispensing a material from a container, said methodcomprising the steps of; Authentication of a first user to a key by oneor more biometric means of identification; Communication of the dataproduced by authentication to a means for analysing the data; Analysisof the communicated data to determine whether the first user ispermitted to access restricted functions of the system; Access torestricted functions of the system if the first user is authorised;Authentication of a second user to a control device by one or morebiometric means of identification; Communication of the data produced byauthentication to a means for analysing the data; Analysis of thecommunicated data to determine whether dispensing of the material fromthe container is permitted; and Secure dispensing of material from thecontainer if the second user is authorised.
 38. A method as claimed inclaim 37, wherein the biometric means of authentication is one or moreof the users fingerprints.
 39. A method as claimed in claim 37, whereinthe key, once authenticated, allows the first user to open the containerto enable the contents of container to be replaced.
 40. A method asclaimed in claim 37, wherein the key, once authenticated, allows thefirst user to programme the control device to enable dispensing ofmaterial according to a regime.
 41. A method as claimed in claim 37,wherein the communication of data between the control device and thecontainer is achieved by RFID tags.
 42. A method as claimed in claim 37,wherein the material to be dispensed is a pharmaceutical product.